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Trial registered on ANZCTR


Registration number
ACTRN12613000216718
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the revised version of Reasoning and Rehabilitation (R&R2) cognitive skills programme in high risk male offenders with severe mental illness
Scientific title
A quasi-experimental waiting list controlled trial of cognitive behaviour therapy in mentally disordered offenders: the impact on completion, attitudes towards violence, anger, coping processes, social problem solving, and ward behaviour (disruptive behaviour and social problems).
Secondary ID [1] 282004 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychosis 288443 0
antisocial personality disorder/behaviour 288445 0
dysfunctional psychological coping processes 288446 0
anger 288447 0
social problem solving deficits 288448 0
poor social functioning 288449 0
Condition category
Condition code
Mental Health 288791 288791 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
R&R2 is a manualised cognitive-behavioral intervention developed for antisocial youths and adults with mental health problems. It consists of 16, 90-minute, sessions which run on a weekly basis. It is a revised version of the original 36-session R&R programme and aims to reduce anti-social behavior and attitudes and improve pro-social thinking, cognitive and problem-solving skills. The programme employs a variety of methods to engage individuals such as individual group exercises, audiovisual material and workbooks which include homework assignments. The programme consists of 5 treatment modules: (1) a neuro-cognitive model which introduces techniques to increase attentional control, impulse control, memory and constructive planning; (2) a problem-solving module which encourages problem identification, generation of multiple alternative solutions and consequential thinking; (3) an emotional control module which involves management of anxiety, anger and conflict; (4) a social skills module which aims to increase awareness of the thoughts and feelings of others; and (5) a critical reasoning module which aims to develop skills in the assessment and evaluation of information. The R&R2 programme combines group and individual treatment. Individual treatment incorporates the use of a mentoring paradigm, whereby a mentor provides coaching sessions outside of group sessions. Their purpose is to facilitate the transfer of skills learned in group sessions into daily activities. Mentors are provided with written guidance on how to structure individual sessions. R&R2 facilitators are provided with training in how to deliver the programme. Programme integrity and consistency is ensured through (1) regular steering committee meetings; (2) random observations of group sessions by one of the programme authors; and (3) group supervision meetings of facilitators to prepare for sessions, process and discuss sessions that had been delivered and (4) regular meetings and supervision between program facilitators and mentors. Furthermore, R&R2 maximises programme integrity by fostering consistency through its structured, manualised design. Assessments are made at baseline and 16 weeks later at the end of treatment phase.
Intervention code [1] 286577 0
Rehabilitation
Intervention code [2] 286578 0
Lifestyle
Intervention code [3] 286579 0
Behaviour
Comparator / control treatment
Waiting list control group who continue their treatment as usual (both pharmacological and nonpharmacological). Other treatments are not controlled for. Control group is not asked to refrain from engaging in other interventions during the study period but they are not permitted to attend the R&R2 programme during the study period. They are assessed at baseline and 16 weeks later at the end of treatment phase. They are offered the intervention thereafter.
Control group
Active

Outcomes
Primary outcome [1] 288931 0
Maudsley Violence Questionnaire (Walker, 2005) to assess violent attitudes (machismo and acceptance of violence)
Timepoint [1] 288931 0
Both conditions tested at baseline and at end of treatment phase (16 weeks later).
Secondary outcome [1] 301379 0
Novaco Anger Scale - Provocation Inventory: Reaction to Provocation/Personal Affect Questionnaire (NAS-PI) (Novaco, 2003) to assess cognitive, arousal and behavioral domains of anger experience.
Timepoint [1] 301379 0
Both conditions tested at baseline and at end of treatment phase (16 weeks later).
Secondary outcome [2] 301380 0
Ways of Coping Scale (Lazarus & Folkman, 1984) to assess coping processes includinkg confrontation, distancing, self-control, social support, accepting responsibility, escape/avoidance, planful problem-solving, positive reappraisal
Timepoint [2] 301380 0
Both conditions tested at baseline and at end of treatment phase (16 weeks later).
Secondary outcome [3] 301381 0
Social Problem-Solving Inventory-Revised: Short (SPSI-R: S) (D'Zurilla, Nezu & Maydeu-Olivares, 1994) to assess aspects of social problem solving including two problem-solving orientations (positive and negative) and three problem-solving styles (rational problem-solving, impulsivity/carelessness and avoidant).
Timepoint [3] 301381 0
Both conditions tested at baseline and at end of treatment phase (16 weeks later).
Secondary outcome [4] 301382 0
Disruptive Behavior and Social Problems Scale (DBSP) (Young, Gudjonsson, Ball & Lam, 2003) to assess ward behaviour including disruptive behaviour, social and psychological functioning.
Timepoint [4] 301382 0
Both conditions tested at baseline and at end of treatment phase (16 weeks later).

Eligibility
Key inclusion criteria
History of severe mental illness, history of violence and/or antisocial behaviour, proficiency in English language, mental stability at the time of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous participation in R&R programme, history of learning disability, patients posing risk of violence to the researcher(s).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
26/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4879 0
United Kingdom
State/province [1] 4879 0

Funding & Sponsors
Funding source category [1] 286782 0
Hospital
Name [1] 286782 0
Broadmoor Hospital
Country [1] 286782 0
United Kingdom
Primary sponsor type
Hospital
Name
Broadmoor Hospital
Address
Crowthorne
Berkshire
RG45 7EG
Country
United Kingdom
Secondary sponsor category [1] 285565 0
University
Name [1] 285565 0
King's College London, Institute of Psychiatry
Address [1] 285565 0
De Crespigny Park
London
SE5 8AF
Country [1] 285565 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288849 0
Ealing and West London Research Ethics Committee
Ethics committee address [1] 288849 0
Ethics committee country [1] 288849 0
United Kingdom
Date submitted for ethics approval [1] 288849 0
17/03/2011
Approval date [1] 288849 0
03/05/2011
Ethics approval number [1] 288849 0
09/H0710/46

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38050 0
Dr Susan Young
Address 38050 0
Department of Forensic Mental Health Sciences, PO23
Kings College London, Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
Country 38050 0
United Kingdom
Phone 38050 0
+442078485280
Fax 38050 0
Email 38050 0
susan.young@kcl.ac.uk
Contact person for public queries
Name 38051 0
Susan Young
Address 38051 0
Department of Forensic Mental Health Sciences, PO23
Kings College London, Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
Country 38051 0
United Kingdom
Phone 38051 0
+442078485280
Fax 38051 0
Email 38051 0
susan.young@kcl.ac.uk
Contact person for scientific queries
Name 38052 0
Susan Young
Address 38052 0
Department of Forensic Mental Health Sciences, PO23
Kings College London, Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
Country 38052 0
United Kingdom
Phone 38052 0
+442078485280
Fax 38052 0
Email 38052 0
susan.young@kcl.ac.uk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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